Interim Assessment of the Program for Enhanced Review Transparency and Communication; Public Meeting and Establishment of Docket, 22532-22534 [2015-09300]
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<![CDATA[
22532
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
responses per
respondent
Number of
respondents
Type of submission
Total annual
responses
Average
burden per
response
(hours)
Total hours
199
200
6
26
4
7
60
2.5
2.5
1
2
1.5
1
1
499
500
6
52
6
7
60
50
2
2
12
12
12
12
24,950
1,000
12
624
72
84
720
Total ............................................................................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Promotional labeling submitted for advisory comments,
including resubmissions and amendments ....................
General correspondence submitted to FDA ......................
Requests to withdraw a previous submission to FDA .......
Responses to untitled or warning letters ...........................
Responses to information requests ...................................
Reference documents ........................................................
Complaints submitted to OPDP .........................................
........................
..........................
........................
........................
27,462
This draft guidance also refers to
previously approved collections of
information found in FDA regulations
and collections of information that are
currently under OMB review. The
collections of information in 21 CFR
202.1, including requests for advisory
comments, resubmissions, and
amendments for advertisements, have
been approved under OMB control
number 0910–0686; the collections of
information in 21 CFR 601.45
(presubmission of promotional materials
for accelerated approval products under
part 601) have been approved under
OMB control number 0910–0338; the
collections of information for FDA Form
2253 and the presubmission of
promotional materials for accelerated
approval products under part 314 have
been approved under OMB control
number 0910–0001. FDA has also
published in the Federal Register a 60day notice soliciting public comments
on the collections of information that
result from the submission of television
advertisements under section 503C of
the FD&C Act (21 U.S.C. 353c) (77 FR
14811, March 13, 2012). These burden
estimates do not change as a result of
this guidance. This is because new
burdens for establishing the means for
submitting materials in electronic form
to comply with this guidance would be
negated by the savings in burden from
not having to print out the materials and
mail them to FDA.
Some firms may incur costs
associated with upgrading technology or
changing the method of submitting
information to FDA, and these have
been described in the Federal Register
notice for the revised draft guidance for
industry entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Certain Human Pharmaceutical Product
Applications and Related Submissions
Using the Electronic Common Technical
Document Specifications’’ (79 FR 43494,
July 25, 2014).
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
www.regulations.gov.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09297 Filed 4–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0093]
Interim Assessment of the Program for
Enhanced Review Transparency and
Communication; Public Meeting and
Establishment of Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting and
establishment of docket; request for
comments.
ACTION:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing the
establishment of a docket to obtain
comments on the interim assessment of
the Program for Enhanced Review
Transparency and Communication for
New Molecular Entity (NME) New Drug
Applications (NDAs) and Original
Biologics License Applications (BLAs)
(the Program). FDA is also announcing
a public meeting where the interim
assessment will be discussed and public
stakeholders may present their views on
the Program to date.
The Program is part of the FDA
performance commitments under the
fifth authorization of the Prescription
Drug User Fee Act (PDUFA), which
enables FDA to collect user fees for the
review of human drug and biologics
applications for fiscal years (FYs) 2013–
2017. The Program is described in detail
in section II.B entitled ‘‘PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2013 through
2017.’’ The Program is being evaluated
by an independent contractor with
expertise in assessing the quality and
efficiency of pharmaceutical and
biopharmaceutical development and
regulatory review programs. As part of
FDA’s performance commitments, FDA
is providing a period for public
comment on the interim assessment of
the Program.
SUMMARY:
See Section III, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document for dates and times of the
public meeting, closing dates for
advance registration, requesting special
accommodations due to disability, and
information on deadlines for submitting
either electronic or written comments to
FDA’s Division of Dockets Management.
DATES:
See Section III, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
ADDRESSES:
E:\FR\FM\22APN1.SGM
22APN1
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993, 301–796–
5003, FAX: 301–847–8443,
Graham.Thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The timely review of the safety and
efficacy of new drugs and biologics is
central to FDA’s mission to protect and
promote the public health. Since the
implementation of PDUFA I in 1993,
FDA has used PDUFA resources to
significantly reduce the time it takes to
evaluate new drugs without
compromising FDA’s rigorous standards
for drug safety and efficacy. In return for
these additional resources, FDA agreed
to certain review performance goals,
such as completing reviews of NDAs
and BLAs and taking regulatory actions
on them within predictable timeframes.
These changes revolutionized the
review process and enabled FDA to
improve the efficiency of the
application review process for new
drugs and biologics without
compromising the Agency’s high
standards for demonstration of safety,
efficacy, and quality of new drugs and
biologics prior to approval.
PDUFA provides FDA with a source
of stable, consistent funding that has
made possible our efforts to focus on
promoting innovative therapies and
helping to bring to market critical
products for patients. The PDUFA
program has been reauthorized every 5
years, with the most recent
reauthorization occurring in 2012 for
FYs 2013–2017 (PDUFA V).1
PDUFA V introduced a new review
program for NME NDAs and original
BLAs to enhance review transparency
and communication between FDA and
applicants on these complex
applications. FDA committed to
engaging an independent contractor to
evaluate the Program. The PDUFA V
performance commitments call for an
interim assessment of the Program to be
published by March 31, 2015, for public
comment. The interim assessment can
be accessed at https://www.fda.gov/
downloads/ForIndustry/UserFees/
PrescriptionDrugUserFee/
UCM436448.pdf.
II. PDUFA V NME NDA and Original
BLA Review Program
FDA’s review performance goals for
priority and standard applications, 6
and 10 months respectively, have been
in place since the late 1990s. Since that
time, additional requirements in the
review process and scientific advances
in product development have made
those goals increasingly challenging to
meet, particularly for more complex
applications like NME NDAs and
original BLAs. FDA further recognizes
that increasing communication between
the Agency and applicants during FDA’s
review has the potential to increase
efficiency in the review process.
To promote greater transparency and
improve communication between the
FDA review team and the applicant,
FDA implemented a new review model
for NME NDAs and original BLAs in
PDUFA V. The Program provides
opportunities for increased
communication between FDA and
applicants, including mid-cycle and
late-cycle meetings. To accommodate
the increased interaction during
regulatory review and to address the
need for additional time to review these
complex applications, FDA’s review
clock begins after the 60-day
22533
administrative filing review period for
applications reviewed under the
Program.
The goal of the Program is to improve
the efficiency and effectiveness of the
first-cycle review process by increasing
communications during application
review. This will provide sponsors with
the opportunity to clarify previous
submissions and provide additional
data and analyses that are readily
available, potentially avoiding the need
for an additional review cycle when
concerns can be promptly resolved but
without compromising FDA’ standards
for approval.
To understand the Program’s effect on
the review of these applications, the
Program is being evaluated by an
independent contractor. In addition to
publishing an interim assessment and
opening a docket for public comments,
a public meeting will be held on May
20, 2015, where the interim assessment
will be discussed and public
stakeholders may present their views on
the Program to date. The final
assessment of the Program will be
published for public comment by
December 31, 2016, and will be
followed by a public meeting by March
30, 2017.
III. How To Participate in the Public
Meeting
FDA is holding the public meeting on
May 20, 2015, from 10 a.m. to 1 p.m.
Due to limited space and time, we
encourage all persons who wish to
attend the meeting to register in
advance. There is no fee to register for
the public meeting, and registration will
be on a first-come, first-served basis.
Table 1 of this document provides
information on participation in the
public meeting.
TABLE 1—INFORMATION ON PARTICIPATING IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET 1
Dates
Electronic addresses
Addresses
Other information
Participants must enter through
Building 1 and undergo security screening. For more information on parking and security
procedures, please visit https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
There is no registration fee for
the public meeting.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Attend public
meeting.
May 20, 2015,
from 10 a.m.
to 1 p.m.
Please preregister at https://
www.nmepdufa.eventbrite.com.
FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, Section A
of the Great Room (Rm. 1503)
Silver Spring, MD 20993.
Preregister ...........
Register by May
13, 2015.
Individuals who wish to participate in person are asked to
preregister at https://www.
nmepdufa.eventbrite.com.
We encourage the use of electronic registration, if possible.1
1 This document is available on the Internet at
https://www.fda.gov/downloads/ForIndustry/
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
UserFees/PrescriptionDrugUserFee/
UCM270412.pdf.
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Sfmt 4703
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22APN1
22534
Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
TABLE 1—INFORMATION ON PARTICIPATING IN THE MEETING AND ON SUBMITTING COMMENTS TO THE DOCKET 1—
Continued
Dates
Electronic addresses
View Web cast ....
May 20, 2015,
from 10 a.m.
to 1 p.m.
Request special
accommodations due to disability.
Submit electronic
or written comments.
Request at least
7 days before
the meeting.
Addresses
Other information
Individuals who are unable to attend the meeting in person,
can register to view a live Web
cast. You will be asked to indicate in your registration whether you plan to attend in person
or via the Web cast.
Graham Thompson, email: Graham.Thompson@fda.hhs.gov.
......................................................
The Web cast will have closed
captioning.
Submit comFederal eRulemaking Portal:
ments by
https://www.regulations.gov. FolJune 30, 2015.
low the instructions for submitting comments.
See FOR FURTHER INFORMATION CONTACT.
Mail/Hand delivery/Courier (for
paper submissions): Division of
Dockets Management (HFA–
305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD
20852.
Identify your comments with the
docket number listed in brackets in the heading of this document. We encourage you to
submit electronic comments by
using the Federal eRulemaking
Portal.
1 You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration information and send to: Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301–796–5003, FAX: 301–847–8443, Graham.Thompson@fda.hhs.gov.
IV. Comments and Transcripts
Regardless of attendance at the public
meeting, interested persons may submit
to FDA’s Division of Dockets
Management (see Addresses in table 1)
either electronic or written comments
on the interim assessment of the
Program for Enhanced Review
Transparency and Communication for
NME NDAs and Original BLAs. You
only need to send one set of comments.
Identify the comments with the docket
number provided in brackets in the
heading of this document.
With respect to transcripts, please be
advised that as soon as a transcript is
available, it will be accessible at
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm327030.htm.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09300 Filed 4–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Office of the Secretary
Ebola Virus Disease Therapeutics
Notice of Declaration Under the
Public Readiness and Emergency
Preparedness Act.
ACTION:
The Secretary is issuing a
Declaration pursuant to section 319F–3
of the Public Health Service Act (42
U.S.C. 247d–6d) to provide liability
SUMMARY:
VerDate Sep<11>2014
18:00 Apr 21, 2015
Jkt 235001
protection for activities related to Ebola
Virus Disease Therapeutics consistent
with the terms of the Declaration.
DATES: The Declaration is effective as of
February 27, 2015.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, MD, MSPH, Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Background
The Public Readiness and Emergency
Preparedness Act (‘‘PREP Act’’)
authorizes the Secretary of Health and
Human Services (‘‘the Secretary’’) to
issue a Declaration to provide liability
immunity to certain individuals and
entities (‘‘Covered Persons’’) against any
claim of loss caused by, arising out of,
relating to, or resulting from the
administration or use of medical
countermeasures (‘‘Covered
Countermeasures’’), except for claims
that meet the PREP Act’s definition of
willful misconduct. Using this
authority, the Secretary is issuing a
Declaration to provide liability
immunity to Covered Persons for
activities related to the Covered
Countermeasures, Ebola Virus Disease
Therapeutics as listed in Section VI of
the Declaration, consistent with the
terms of this Declaration.
The PREP Act was enacted on
December 30, 2005, as Public Law 109–
148, Division C, Section 2. It amended
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
the Public Health Service (‘‘PHS’’) Act,
adding section 319F–3, which addresses
liability immunity, and section 319F–4,
which creates a compensation program.
These sections are codified in the U.S.
Code as 42 U.S.C. 247d–6d and 42
U.S.C. 247d–6e, respectively.
The Pandemic and All-Hazards
Preparedness Reauthorization Act
(PAHPRA), Public Law 113–5, was
enacted on March 13, 2013. Among
other things, PAHPRA added sections
564A and 564B to the Federal Food,
Drug, and Cosmetic (FD&C) Act to
provide new emergency authorities for
dispensing approved products in
emergencies and products held for
emergency use.
PAHPRA accordingly amended the
definitions of ‘‘Covered
Countermeasures’’ and ‘‘qualified
pandemic and epidemic products’’ in
section 319F–3 of the Public Health
Service Act (the PREP Act provisions),
so that products made available under
these new FD&C Act authorities could
be covered under PREP Act
Declarations. PAHPRA also extended
the definition of qualified pandemic and
epidemic products that may be covered
under a PREP Act Declaration to include
products or technologies intended to
enhance the use or effect of a drug,
biological product, or device used
against the pandemic or epidemic or
against adverse events from these
products.
The Ebola virus causes an acute,
serious illness that is often fatal. Since
March 2014, West Africa has been
experiencing the largest and most
complex Ebola outbreak since the Ebola
E:\FR\FM\22APN1.SGM
22APN1
]]>Agencies
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22532-22534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09300]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0093]
Interim Assessment of the Program for Enhanced Review
Transparency and Communication; Public Meeting and Establishment of
Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting and establishment of docket; request
for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a docket to obtain comments on the interim assessment
of the Program for Enhanced Review Transparency and Communication for
New Molecular Entity (NME) New Drug Applications (NDAs) and Original
Biologics License Applications (BLAs) (the Program). FDA is also
announcing a public meeting where the interim assessment will be
discussed and public stakeholders may present their views on the
Program to date.
The Program is part of the FDA performance commitments under the
fifth authorization of the Prescription Drug User Fee Act (PDUFA),
which enables FDA to collect user fees for the review of human drug and
biologics applications for fiscal years (FYs) 2013-2017. The Program is
described in detail in section II.B entitled ``PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2013 through 2017.'' The
Program is being evaluated by an independent contractor with expertise
in assessing the quality and efficiency of pharmaceutical and
biopharmaceutical development and regulatory review programs. As part
of FDA's performance commitments, FDA is providing a period for public
comment on the interim assessment of the Program.
DATES: See Section III, ``How to Participate in the Public Meeting'' in
the SUPPLEMENTARY INFORMATION section of this document for dates and
times of the public meeting, closing dates for advance registration,
requesting special accommodations due to disability, and information on
deadlines for submitting either electronic or written comments to FDA's
Division of Dockets Management.
ADDRESSES: See Section III, ``How to Participate in the Public
Meeting'' in the SUPPLEMENTARY INFORMATION section of this document.
[[Page 22533]]
FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443, Graham.Thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The timely review of the safety and efficacy of new drugs and
biologics is central to FDA's mission to protect and promote the public
health. Since the implementation of PDUFA I in 1993, FDA has used PDUFA
resources to significantly reduce the time it takes to evaluate new
drugs without compromising FDA's rigorous standards for drug safety and
efficacy. In return for these additional resources, FDA agreed to
certain review performance goals, such as completing reviews of NDAs
and BLAs and taking regulatory actions on them within predictable
timeframes. These changes revolutionized the review process and enabled
FDA to improve the efficiency of the application review process for new
drugs and biologics without compromising the Agency's high standards
for demonstration of safety, efficacy, and quality of new drugs and
biologics prior to approval.
PDUFA provides FDA with a source of stable, consistent funding that
has made possible our efforts to focus on promoting innovative
therapies and helping to bring to market critical products for
patients. The PDUFA program has been reauthorized every 5 years, with
the most recent reauthorization occurring in 2012 for FYs 2013-2017
(PDUFA V).\1\
---------------------------------------------------------------------------
\1\ This document is available on the Internet at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
---------------------------------------------------------------------------
PDUFA V introduced a new review program for NME NDAs and original
BLAs to enhance review transparency and communication between FDA and
applicants on these complex applications. FDA committed to engaging an
independent contractor to evaluate the Program. The PDUFA V performance
commitments call for an interim assessment of the Program to be
published by March 31, 2015, for public comment. The interim assessment
can be accessed at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM436448.pdf.
II. PDUFA V NME NDA and Original BLA Review Program
FDA's review performance goals for priority and standard
applications, 6 and 10 months respectively, have been in place since
the late 1990s. Since that time, additional requirements in the review
process and scientific advances in product development have made those
goals increasingly challenging to meet, particularly for more complex
applications like NME NDAs and original BLAs. FDA further recognizes
that increasing communication between the Agency and applicants during
FDA's review has the potential to increase efficiency in the review
process.
To promote greater transparency and improve communication between
the FDA review team and the applicant, FDA implemented a new review
model for NME NDAs and original BLAs in PDUFA V. The Program provides
opportunities for increased communication between FDA and applicants,
including mid-cycle and late-cycle meetings. To accommodate the
increased interaction during regulatory review and to address the need
for additional time to review these complex applications, FDA's review
clock begins after the 60-day administrative filing review period for
applications reviewed under the Program.
The goal of the Program is to improve the efficiency and
effectiveness of the first-cycle review process by increasing
communications during application review. This will provide sponsors
with the opportunity to clarify previous submissions and provide
additional data and analyses that are readily available, potentially
avoiding the need for an additional review cycle when concerns can be
promptly resolved but without compromising FDA' standards for approval.
To understand the Program's effect on the review of these
applications, the Program is being evaluated by an independent
contractor. In addition to publishing an interim assessment and opening
a docket for public comments, a public meeting will be held on May 20,
2015, where the interim assessment will be discussed and public
stakeholders may present their views on the Program to date. The final
assessment of the Program will be published for public comment by
December 31, 2016, and will be followed by a public meeting by March
30, 2017.
III. How To Participate in the Public Meeting
FDA is holding the public meeting on May 20, 2015, from 10 a.m. to
1 p.m. Due to limited space and time, we encourage all persons who wish
to attend the meeting to register in advance. There is no fee to
register for the public meeting, and registration will be on a first-
come, first-served basis.
Table 1 of this document provides information on participation in
the public meeting.
Table 1--Information on Participating in the Meeting and on Submitting Comments to the Docket \1\
----------------------------------------------------------------------------------------------------------------
Dates Electronic addresses Addresses Other information
----------------------------------------------------------------------------------------------------------------
Attend public meeting........ May 20, 2015, Please preregister FDA White Oak Participants must
from 10 a.m. at https:// Campus, 10903 New enter through
to 1 p.m. www.nmepdufa.eventb Hampshire Ave., Building 1 and
rite.com. Bldg. 31 Conference undergo security
Center, Section A screening. For more
of the Great Room information on
(Rm. 1503) Silver parking and
Spring, MD 20993. security
procedures, please
visit https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Preregister.................. Register by May Individuals who wish We encourage the use There is no
13, 2015. to participate in of electronic registration fee
person are asked to registration, if for the public
preregister at possible.\1\ meeting.
https://www.nmepdufa.eventbrite.com.
[[Page 22534]]
View Web cast................ May 20, 2015, Individuals who are .................... The Web cast will
from 10 a.m. unable to attend have closed
to 1 p.m. the meeting in captioning.
person, can
register to view a
live Web cast. You
will be asked to
indicate in your
registration
whether you plan to
attend in person or
via the Web cast.
Request special Request at Graham Thompson, See FOR FURTHER
accommodations due to least 7 days email: INFORMATION CONTACT.
disability. before the Graham.Thompson@fda
meeting. .hhs.gov.
Submit electronic or written Submit comments Federal eRulemaking Mail/Hand delivery/ Identify your
comments. by June 30, Portal: https:// Courier (for paper comments with the
2015. www.regulations.gov submissions): docket number
. Follow the Division of Dockets listed in brackets
instructions for Management (HFA- in the heading of
submitting comments. 305), Food and Drug this document. We
Administration, encourage you to
5630 Fishers Lane, submit electronic
Rm. 1061, comments by using
Rockville, MD 20852. the Federal
eRulemaking Portal.
----------------------------------------------------------------------------------------------------------------
\1\ You may also register via email, mail, or fax. Please include your name, title, firm name, address, and
phone and fax numbers in your registration information and send to: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver
Spring, MD 20993, 301-796-5003, FAX: 301-847-8443, Graham.Thompson@fda.hhs.gov.
IV. Comments and Transcripts
Regardless of attendance at the public meeting, interested persons
may submit to FDA's Division of Dockets Management (see Addresses in
table 1) either electronic or written comments on the interim
assessment of the Program for Enhanced Review Transparency and
Communication for NME NDAs and Original BLAs. You only need to send one
set of comments. Identify the comments with the docket number provided
in brackets in the heading of this document.
With respect to transcripts, please be advised that as soon as a
transcript is available, it will be accessible at www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09300 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P
